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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

476413 — Class IIa MDD by Biomedical S.r.l.

MD Atlas
Biomedical S.r.l.

EUDAMED last updated this device on Sep 5, 2023

476413

B-08053670913097

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Biomedical S.r.l.
UDI-DI code: 08053670913097
Reference / catalog number: 476413

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View device family (Basic UDI)

Manufacturer information

Organization name: Biomedical S.r.l.
SRN: IT-MF-000027821
Manufacturer status: Active

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0BC1615B-08053670911772On the market 0BC1710B-08053670911802On the market 0BC1810B-08053670911840On the market 0BC1815B-08053670911864On the market 0BD1410B-08053670912052On the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

4 warnings recorded — scroll inside the panel to see all entries.

CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08053670913097
Basic UDI-DI: B-08053670913097
Reference / catalog number: 476413
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

A01020201ILIAC-STERNAL BIOPSY NEEDLES AND KITS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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